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Antiinfectives for Systemic Use

Tubertam (Injections)
(Ethambutol)



CONTENT:
Ampoules. Ampoule contains ethambutol dihydrochloride
500 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Tubertam is an antituberculosis, antibacterial, bacteriostatic drug.
The active ingredient is ethambutol dihydrochloride, which quickly penetrates into bacterial cell, affects ribosome structure, RNAand protein synthesis, lipidic exchange, binds ions of magnesium and copper. It inhibits the ferments, participating in synthesis of cellular mycobacterial wall. It acts only on intensively dividing mycobacteria located extra- and intracellularly (intracellular concentrations exceed extracellular concentrations twice).
Drug is effective against Mycobacterium tuberculosis (MIC 1-2 mg/ml), resistant to streptomycin, isoniazid, PASA, kanamycin, ethionamide, and also Mycobacterium kansasii (MIC 16 mg/ml).
About 1 % of strains have primary resistance to ethambutol.
The resistance slowly develops during monotherapy with ethambutol. The effect develops in 1-2 days. It inhibits the development of resistance to other antituberculous drugs; crossover resistance is not observed.
PHARMACOKINETICS. High Tubertam concentration in blood after injection is
maintained for 2-4 h. Binding with plasma proteins is 20-30%. It easily penetrates into
tissues and organs, body fluids with exception of ascitic and pleural fluid. It is revealed in
cerebrospinal fluid during tuberculous meningitis. The highest concentrations are
determined in kidney, lungs, saliva, urine. It penetrates in breast milk. It doesn't cross
intact blood-brain barrier. It is partially metabolized in liver (15%) with formation of
inactive metabolites. The half-life period is 6 h, and at the disorder of kidney function - 8 h. It is removed with urine (80-90%, from them 50% is unchanged, 15% - as inactive
metabolites) and faeces (10-20% is unchanged). It is excreted during hemodialysis and
peritoneal dialysis.
 
THERAPEUTIC INDICATIONS:
- combined therapy of all tuberculosis forms.
 
CONTRAINDICATIONS:
- hypersensitization to ethambutol;
- optic neuritis;
- cataract;
- inflammatory diseases of eye;
- diabetic retinopathy;
- gout;
- compromised kidney function;
- pregnancy, infancy up to 13 years.
 
SIDE EFFECTS:
From nervous system and organs of sense: depression, dizziness, headache, disorientation in space, hallucinations, peripheral neuritis and polyneuropathy, retrobulbar neuritis, optic atrophy; deterioration of visual acuity, refractions and chromatic sensitivity (mainly, green and red colors), the constriction of central and circumferential field of vision.
From organs of gastrointestinal tract: dyspeptic effects, abdominal pain, compromised liver function.
Allergic reactions: skin eruption, itch.
Other: leukocytopenia, hyperuricemy, exacerbation of podagra, arthralgia.
 
DOSAGEAND ADMINISTRATION:
For intravenous and intramuscular injection.
Doses are set by the doctor individually depending on body weight.
At intramuscular injection:
Adults: 15-25 mg/kg of body weight in 1 -2 injections. Children up to 13 years: 25-30 mg/kg of body weight per day. At intravenous administration:
The drug is administered in doses of 25 mg/kg of body weight. Dose can be decreased up to 15 mg/kg of body weight, and then therapy can be switched for oral administration in dose of500 mg.
The preparation of solution for intravenous infusion.
The contents of one or a few ampoules are diluted in 500 ml of physiological solution or
5% glucose solution.
 
PACKAGING:
10 ampoules in a contour tray.
Contour tray in a carton box with enclosed leaflet.
 
 
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